Cleared Traditional

IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET

K140554 · Immunodiagnostic Systems , Ltd. · Chemistry
Dec 2014
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K140554 is an FDA 510(k) clearance for the IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on December 19, 2014, 290 days after receiving the submission on March 4, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K140554 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2014
Decision Date December 19, 2014
Days to Decision 290 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRG — System, Test, Vitamin D
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1825

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